A new study called FirstX is now enrolling participants and will examine a compound called CXA-10 in primary FSGS as a first-line drug for people who would normally have been treated with high-dose steroids. CXA-10 is in a class of oral compounds called nitrated fatty acids. It is a signaling agent with anti-inflammatory/immunomodulatory, antifibrotic, antioxidative, and other properties that are important in the pathobiology of FSGS, according to an abstract for the trial presented during ASN Kidney Week 2018.
Primary FSGS is often treated with steroids, but side effects of prolonged use may include obesity, hypertension, growth impairment, diabetes, and immune suppression.
A phase 2, multicenter, randomized, open-label study, FirstX will evaluate the efficacy and safety of CXA 10 in approximately 30 participants. The study is sponsored by clinical-stage biopharmaceutical firm Complexa Inc. in Berwyn, Pennsylvania. Eligible patients include adults with biopsy-proven primary FSGS who have not received treatment for FSGS with high-dose, long-term steroids (or other immunosuppressive therapy). Patients will be randomized into one of two possible groups and will receive CXA-10 treatment for 3 months. The primary efficacy endpoint is reduction in proteinuria. Other efficacy endpoints include markers of nephrotic syndrome, kidney function (estimated GFR), biomarkers relevant to the disease, and patient-reported outcomes.
Complexa is partnering with the Kidney Research Network, University of Michigan Data Coordinating Center, and NephCure Kidney International to conduct the trial.
